Categorized as: Regulatory affairs

We strengthen Regulatory/QA capabilities by hiring Gert Nielsen

As part of a continued focus on delivering high-value RA/QA consulting for medical device companies, Medicologic has hired Gert Nielsen in the role as Senior Regulatory Affairs Consultant.

Gert NielsenGert has almost 20 years of experience within Regulatory Affairs, working for a number of med-tech companies including Ambu, Radiometer and GE Medical Systems. Lately, he worked four and a half years for ultrasound equipment manufacturer BK Medical. At Medicologic Gert’s primary responsibility will be to support clients by developing classification and mapping of regulatory strategies, creating technical files and design history files as well as preparation and submissions of FDA 510(k) and international applications. Gert will also be working as a QP (Qualified Person) for selected clients.

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Medical devices: deal reached on new EU rules

On 25 May 2016, the EU agreed new rules on medical devices and in vitro diagnostic medical devices.

eu mapThe Netherlands presidency of the Council and representatives of the European Parliament reached a political agreement. It is still subject to approval by the Council’s Permanent Representatives Committee and of the Parliament’s ENVI committee.

The agreed two draft regulations are expected to achieve a twofold aim: making sure that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit from innovative health care solutions in a timely manner.

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We are moving to new offices in Ørestaden

1st of October 2014, we’ll be moving to our new modern office space in Ørestaden with plenty of room for both development and growth.

We have in recent years experienced a significant increase in demand and positive growth within our competences: End-to-End Medical Device Consulting, Research & Development, Quality Assurance and Regulatory Affairs.

We have a clear ambition for further growth and a desire to expand our network of customers and partners. With the new office we will have plenty of room for both development and growth.

We look forward to move into our new office, which is located in an international environment in Ørestaden and centrally located for the metropolitan area, Southern Sweden, train, metro, the highway network and Copenhagen airport.

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Our new address is:

Medicologic A/S
Arne Jacobsens Alle 15-17
2300 København S

You can still contact us using the same telephone numbers and emails.

We look forward to inviting you to our new office.

Best regards,
Medicologic

We’re looking for a RA & QA Senior Consultant

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About the job
We bring new products to market, applying global legislation, ensuring quality, cost reduction, and timeline requirements.
We are growing and thus need additional resources.

– If adding value, identifying and meeting customer needs in a growth environment motivates you?
– If you have the abilities to lead – as well as the urge to further develop and grow our RA & Quality Team?
– If the combination of solid hands-on RA and Quality work, Team-development as well as direct sales activities will suit your extrovert personality?
– If a flat organization, an entrepreneurial spirit combined with solid expertise and sparring partners within respectively RA and Quality is the right settings for you to live you full potential?
– And if our new location in super attractive surroundings in Örestaden will motivate you even a bit further?

Then, feel free to consider this position.

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